Treatment for recurrent and refractory solid tumors using IMA402

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety, tolerability, and anti-tumor activity of IMA402, a T Cell-Engaging Receptor Molecule, in patients with recurrent and/or refractory solid tumors. The study is conducted in two phases: Phase Ia focuses on dose escalation to determine the maximum tolerated dose, while Phase Ib and II assess the drug's efficacy and safety in specific cohorts. Patients must have advanced solid tumors that have not responded to standard treatments, and the study will monitor their response to IMA402 over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients ≥ 18 years old
* Patients must have a specific pathologically confirmed and documented advanced and/or metastatic solid tumor indication
* Patients must have received or not be eligible for indicated standard-of-care treatments per cohort
* Measurable disease according to RECIST 1.1
* Confirmed HLA status
* ECOG Performance Status of 0 to 1
* Adequate baseline hematologic, hepatic and renal function, acceptable coagulation status

Exclusion Criteria:

* Other active malignancies that require treatment or that might interfere with the trial endpoints
* The patient is pregnant or is breastfeeding
* History of hypersensitivity to components of IMA402 or rescue medications; hypersensitivity to or contraindication according to current SmPC for respective combination medicinal product
* The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator's or sponsor's judgement, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures
* Patients with active brain metastases, history of bleeding into brain metastases, known brain metastases who are receiving therapeutic anticoagulation

Where it's running

• Universitaetsklinikum Heidelberg AöR
  Heidelberg, Baden-Wurttemberg, Germany Recruiting
• Thoraxklinik Heidelberg gGmbH
  Heidelberg, Baden-Wurttemberg, Germany Recruiting
• Universitaetsklinikum Mannheim GmbH
  Mannheim, Baden-Wurttemberg, Germany Recruiting
• Universitaetsklinikum Tuebingen AöR
  Tübingen, Baden-Wurttemberg, Germany Recruiting
• Universitaetsklinikum Ulm AöR
  Ulm, Baden-Wurttemberg, Germany Recruiting
• Universitaetsklinikum Erlangen AöR
  Erlangen, Bavaria, Germany Recruiting

Study contacts

• Study coordinator: Immatics Biotechnologies GmbH
• Email: Ctgovinquiries@immatics.com
• Phone: Please E-Mail

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.